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Obesity Surgery
Published in: Obesity Surgery 5/2016

01-05-2016 | Original Contributions

Intermittent Vagal Nerve Block for Improvements in Obesity, Cardiovascular Risk Factors, and Glycemic Control in Patients with Type 2 Diabetes Mellitus: 2-Year Results of the VBLOC DM2 Study

Authors: Scott A. Shikora, James Toouli, Miguel F Herrera, Bård Kulseng, Roy Brancatisano, Lilian Kow, Juan P. Pantoja, Gjermund Johnsen, Anthony Brancatisano, Katherine S. Tweden, Mark B. Knudson, Charles J. Billingto

Published in: Obesity Surgery | Issue 5/2016

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Abstract

Background

One-year results of the VBLOC DM2 study found that intermittent vagal blocking (VBLOC therapy) was safe among subjects with obesity and type 2 diabetes mellitus (T2DM) and led to significant weight loss and improvements in glycemic parameters and cardiovascular risk factors. Longer-term data are needed to determine whether the results are sustained.

Methods

VBLOC DM2 is a prospective, observational study of 28 subjects with T2DM and body mass index (BMI) between 30 and 40 kg/m2 to assess mid-term safety and weight loss and improvements in glycemic parameters, and other cardiovascular risk factors with VBLOC therapy. Continuous outcome variables are reported using mixed models.

Results

At 24 months, the mean percentage of excess weight loss was 22 % (95 % CI, 15 to 28, p < 0.0001) or 7.0 % total body weight loss (95 % CI, 5.0 to 9.0, p < 0.0001). Hemoglobin A1c decreased by 0.6 percentage points (95 % CI, 0.2 to 1.0, p = 0.0026) on average from 7.8 % at baseline. Fasting plasma glucose declined by 15 mg/dL (95 % CI, 0 to 29, p = 0.0564) on average from 151 mg/dL at baseline. Among subjects who were hypertensive at baseline, systolic blood pressure declined 10 mmHg (95 % CI, 2 to 19, p = 0.02), diastolic blood pressure declined by 6 mmHg (95 % CI, 0 to 12, p = 0.0423), and mean arterial pressure declined 7 mmHg (95 % CI, 2 to 13, p = 0.014). Waist circumference was significantly reduced by 7 cm (95 % CI, 4 to 10, p < 0.0001) from a baseline of 120 cm. The most common adverse events were mild or moderate heartburn, implant site pain, and constipation.

Conclusions

Improvements in obesity and glycemic control were largely sustained after 2 years of treatment with VBLOC therapy with a well-tolerated risk profile.
Appendix
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Metadata
Title
Intermittent Vagal Nerve Block for Improvements in Obesity, Cardiovascular Risk Factors, and Glycemic Control in Patients with Type 2 Diabetes Mellitus: 2-Year Results of the VBLOC DM2 Study
Authors
Scott A. Shikora
James Toouli
Miguel F Herrera
Bård Kulseng
Roy Brancatisano
Lilian Kow
Juan P. Pantoja
Gjermund Johnsen
Anthony Brancatisano
Katherine S. Tweden
Mark B. Knudson
Charles J. Billingto
Publication date
01-05-2016
Publisher
Springer US
Published in
Obesity Surgery / Issue 5/2016
Print ISSN: 0960-8923
Electronic ISSN: 1708-0428
DOI
https://doi.org/10.1007/s11695-015-1914-1

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